Regular readers of Belgravia’s blog will know that the area of JAK inhibition has been consistently looking like the most feasible source for the first ever FDA approved treatments for even the most severe forms of Alopecia Areata.
Alopecia Areata has three main phenotypes – Alopecia Areata, which causes patchy hair loss to the scalp only and generally clears up within a year, Alopecia Totalis which leads to baldness of the head, including scalp and facial hair, and Alopecia Universalis – the most extensive iteration which presents as baldness from head to toe. These are autoimmune diseases which disrupt the hair growth cycle and cause the body to attack its hair follicles to varying degrees in a range of hair-bearing areas.
As we inch closer to the estimated release date of 2021/22, more players are jockeying for pole position in this race to address a currently unmet need.
To this end Incyte Corporation has recently updated the clinical trial registration documentation regarding its Phase 2 and Phase 3 trials for the oral JAK inhibitor, baricitinib. The baricitinib formulation is known by the code LY3009104.
Addressing an unmet need
Over the past few years researchers, particularly those at Columbia University’s medical school in New York, and pharmaceutical companies from Aclaris Therapeutics to Pfizer, have been pulling out all the stops to develop safe, tolerable and effective hair loss solutions from established JAK inhibitor drugs.
Whilst Pfizer’s work in this area has received a Breakthrough Therapy designation from the FDA, both Aclaris Therapeutics and Concert Pharmaceuticals have been granted Fast Track status for their janus kinase (JAK) inhibitor-based formulations. The focus on bringing the most suitable treatments to market as soon as possible is due to the FDA wanting to establish a viable, safe and clinically-proven treatment for these conditions which currently have limited options yet can cause extreme distress to those affected.
Announced in August 2018, Incyte’s wide-ranging interventional, double blind trial started on 24th September 2018, and is taking place at a number of locations across the USA, Japan and Puerto Rico. It involves 725 participants taking one of three pills – high dose baricitinib, low dose baricitinib or a placebo. Their scalp hair growth, eyelash and eyebrow hair changes will be assessed at week 1 and week 36 of the trial.
Trialled on adult participants
All the volunteers are aged 18 to 70 years with confirmed Alopecia Totalis or Alopecia Universalis; those with the more mild to moderate scalp-only phenotype are excluded from the study.
Whilst there are no products currently approved by the FDA or MHRA licensed for the purpose of treating Alopecia Areata, there are clinically-proven medications which have been recognised by both for the treatment of genetic hair loss in both men and women. Hair loss specialists have found that when the topical solutions are consistently applied to the scalp where needed, as directed, they can have a significant effect on the scalp-only form.
Baricitinib is the active ingredient in the existing Incyte drug, Olumiant, designed for the treatment of rheumatoid arthritis – another autoimmune disorder. The 2mg dose of this medication was FDA approved for this purpose only in April 2018 though a higher dose was rejected on the grounds of concerns regarding side effects. This factor has previously been raised in connection with other JAK inhibitors being redeveloped as potential autoimmune hair loss treatments, particularly tofacitinib. It is thought to be the reason other companies are also exploring topical JAK inhibitors, as this delivery method can often help to minimise adverse reactions.
As more information regarding the race to produce the first JAK inhibitor alopecia areata treatment becomes available, we will publish it on the Alopecia section of Belgravia’s hair loss blog, and are cautiously optimistic that everything seems on track with regards the initial estimated release date.
In the meantime, adults concerned about sudden hair fall and bald patches appearing can take advice from a hair loss specialist where their scalp is the only area affected; children under 16 with any form of alopecia and adults with the more extensive phenotypes should consult their GP or dermatologist first, for advice and information.
The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.